MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FV701T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa (#fv701t) was implanted during a procedure performed on (b)(6) 2015.According to the complainant, the shunt showed an underdrainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 12 years; weight: 43 kilograms (kg); height: 160 centimeters (cm); gender: male.Same event as #3004721439-2023-00145.
Additional Manufacturer Narrative
Visual inspection: during the visual inspection a deformation of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism could confirm that with a value of -0,103 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the vertikal position.Adjustment test: the prosa was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found in prosa.To make the proteins / deposits in the valve more visible, they were colored using a staining solution.Result: based on our investigation results, at the time of our investigation, we can determine non-adjustability, deposits, slowed outflow, as well as deformation on the housing surface of the valve.The cause for the non-adjustability and the slowed outflow could be the detected deposits.Excessive pressure exerted, e.G.By the adjustment instrument, may be responsible for the deformation.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROSA VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 17014613
• Report Number: 3004721439-2023-00146
• Device Sequence Number: 7565883
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: 4041906133023
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20026730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 43 KG